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Date: 2023-05-22 Category: Not Applicable State: Union Government Country: India

CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device

Issued by Ministry of Health and Family Welfare · Central Drugs Standard Control Organization

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Executive Summary & Key Takeaways

Here's a summary of the provided policy text: **Executive Summary:** This document, dated May 23, 2023, from the CDSCO, provides an updated list of laboratories authorized to conduct performance evaluations of In Vitro Diagnostic Medical Devices. The list specifies testing facilities for various categories of diagnostics, including reagents and kits for the detection of specific diseases and conditions. The listed laboratories are essential for evaluating the performance and safety of IVD medical devices in India. **Key Points / Main Content:** * **Testing Facilities:** * The document lists multiple laboratories across India authorized for performance evaluation. * These facilities include National Institutes, ICMR Institutes, Medical Colleges, and other research centers. * **In Vitro Diagnostic Medical Devices Categories:** * The listed laboratories are approved to test In Vitro Diagnostic reagents and kits for the detection of: * HIV, HBV, HCV, Blood Grouping, Cancer, Tuberculosis (TB), Malaria, Dengue, Chikungunya, Treponema pallidum (Syphilis), Typhoid, Influenza, Toxoplasma Gondii, Rubella Virus, Cytomegalovirus, Pneumonia, Methicillin-Resistant Staphylococcus Aureus, Entero Virus AB, markers for Congenital disorders, Neisseria Gonorrhoeae, Human Papilloma Virus infection, autoimmune Disorders and human Genetic testing. **Impact Analysis** **In Vitro Diagnostic Medical Device Manufacturers:** * *Impact:* Manufacturers are required to use these CDSCO-approved laboratories for the performance evaluation of their IVD devices before marketing in India. * *Action Required:* Manufacturers must consult the list to select an appropriate, approved laboratory for testing their products. **CDSCO:** * *Impact:* CDSCO is responsible for maintaining and updating this list of approved laboratories. * *Action Required:* CDSCO needs to ensure the listed laboratories adhere to the required standards and guidelines for performance evaluation. **Healthcare Providers and Patients:** * *Impact:* The policy ensures that IVD medical devices used for diagnosis and monitoring meet the required performance standards, leading to more reliable and accurate results. * *Action Required:* Healthcare providers should be aware of the approved laboratories and the importance of using evaluated and approved IVD devices. **Approved Laboratories:** * *Impact:* These laboratories are authorized to conduct performance evaluations of IVD medical devices. * *Action Required:* The laboratories must maintain their accreditation and adhere to the standards set by CDSCO for conducting performance evaluations.

Key Entities Referenced

CDSCO: Central Drugs Standard Control Organisation, the national regulatory body for pharmaceuticals and medical devices in India, which updated the list of Laboratories. In Vitro Diagnostic Medical Device: Medical devices used for in vitro diagnostics, the performance evaluation of which is the subject of the updated list of laboratories. National Institute of Biologicals, Noida, Uttar Pradesh: A testing facility for In Vitro Diagnostic Medical Devices located in Noida, Uttar Pradesh. ICMR-National AIDS Research Institute, Pune, Maharashtra: A testing facility under ICMR for In Vitro Diagnostic Medical Devices located in Pune, Maharashtra. ICMR National Institute of Virology, Pune, Maharashtra: A testing facility under ICMR for In Vitro Diagnostic Medical Devices located in Pune, Maharashtra. Christian Medical College Hospital, Vellore, Tamil Nadu: A testing facility for In Vitro Diagnostic Medical Devices located in Vellore, Tamil Nadu. All India Institute of Medical Sciences, Bathinda, Punjab: A testing facility for In Vitro Diagnostic Medical Devices located in Bathinda, Punjab. Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram, Kerala: A testing facility for In Vitro Diagnostic Medical Devices located in Thiruvananthapuram, Kerala.
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Dated: 23rd May 2023 CDSCO updated list of Laboratories for conducting Performance Evaluation of In - Vitro Diagnostic Medical Device Sr. Category of In vitro Name of Testing facility No. Diagnostics Medical Devices 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 4) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 7) ICMR-National Institute of Cholera and Enteric In-Vitro Diagnostic Diseases, P-33 C.I.T. Road, Scheme-XM, 1. R eagents/ Kits for Beliaghata Kolkata-700010 detection for HIV 8) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 9)National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 10) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda, Punjab-151001 11) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 12) National Centre for Disease Control CSU, Integrated disease surveillance programme, Civil Lines, Delhi, 110054 13) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, In-Vitro Diagnostic Maharashtra, India 2. R eagents/ Kits for 3) ICMR- National Institute of Virology, 20/ A, Dr. detection for HBV Ambedkar Road, Post Box No. 11 Pune 411001, India 4) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Page 1 of 10Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute of Immunohaematology, 13th floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, Maharashtra 400012 7) ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 8) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 9) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 10) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 11)National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 12) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 4) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 5) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 6) ICMR- National Institute of Eipidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu In-Vitro Diagnostic Housing Board, Ayapakkam, Near Ambattur, 3. R eagents/ Kits for Chennai, Tamil Nadu 600077 detection for HCV 7) ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 8) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 9) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 10) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 11)National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 12) Department of Biological Control, Page 2 of 10King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) Indian Red Cross Society, 1, Red Cross Road, New Delhi 3) ICMR- National Institute of Pathology, Sadarjang Hospital Campus, Ansari Nagar West, New Delhi, Delhi 110029 4) ICMR- National Institute of Immunohaematology, 13th floor, New Multistoreyed Building, KEM Hospital Campus, Parel, Mumbai, Maharashtra 400012 5) ICMR-Regional Medical Research Centre, N.E. In vitro Diagnostic Region, P.O.- Lahowal, Dibrugarh - 786 010 Reagents/ Kits for Assam, INDIA 4. Blood Grouping or 6) Rajiv Gandhi Centre for Biotechnology Tissue Typing Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 7) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 8) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 9) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 10) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 1) ICMR- Institute of Cytology and Preventive Oncology (ICPO), I-7, Sector - 39, Noida 201301 Uttar Pradesh, INDIA 2) ICMR- National Institute of Pathology, ICMR- National Institute of Pathology, Sadarjang Hospital Campus, Ansari Nagar West, New Delhi, Delhi 110029 3) ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA 4) Medical College and Hospital (Department of In vitro Diagnostic Oncology/ Medical Oncology), 88, College St, 5. Reagents/ Kits for Calcutta Medical College, College Square, Kolkata, detection of Cancer West Bengal 700073 5) Tata Memorial Hospital, Dr. E Borges Road, Parel, Mumbai - 400 012 India 6) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 7) Tata Medical Center, 14 MAR (E-W), New Town, Rajarhat, Kolkata- 700156 8) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Page 3 of 10Thiruvananthapuram, Kerala 695014 9) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR- National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, Chetpet, Chennai – 600 031, India 2) ICMR- National Jalma Institute of Leprosy and other mycobacterial diseases P.O BOX 101, Dr. M. Miyazaki Marg, Tajganj, Agra – 282001 3) ICMR-Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha 751023 4) National Institute of Tuberculosis & Respiratory Diseases, Sri Aurobindo Marg, Near Qutub Minar New Delhi- 110030 5) National Tuberculosis Institute, 8, Bellary Road, Bangalore 560 003, India, 6) Rajan Babu T.B. Hospital, Kingsway Camp, GTB Nagar, Delhi 110009 7) Shantabai Devarao Shivaram Tuberculosis Research Centre & Rajiv Gandhi Institute of Chest In vitro Diagnostic Diseases, Someshwara Nagar 1st Main Road, 6. R eagents/ Kits for Dharmaram College Post, Bangalore - 560 029 D etection of 8) Dept. of Microbiology, The Postgraduate Institute of Tuberculosis (TB) Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012 9) National Reference Laboratory for Tuberculosis, Department of Microbiology, Bhopal Memorial Hospital & Research Centre, under ICMR, DHR, Raisen Bypass Road, Near Karond Chouraha, Bhopal - 462038 10) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 11) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 12) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 13)National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 1) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 2) ICMR- National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College In vitro Diagnostic Jabalpur, Madhya Pradesh, 482003. 7. R eagents/ Kits for 3) ICMR- Vector Control Research Centre, Medical Detection of Malaria Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006 4) All India Institute of Medical Sciences, Division of Clinical Microbiology & Molecular Medicine, New Delhi-110029 Page 4 of 105) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 7) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR- Vector Control Research Centre, Medical Complex, VCRC Road, Indra Nagar, Priyadarshini Nagar, Puducherry, 605006 2) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 3) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 4) National Institute of Cholera and Enteric Diseases, P- 33, C.I.T. Road, Scheme XM, Beleghata, Kolkata 700010 5) Christian Medical College & Hospital, Ida Scudder Road, Vellore, Tamil Nadu 632004 6) King Institute, Guindy Flyover, Guindy Institutional In vitro Diagnostic Area, SIDCO Industrial Estate, Guindy, Chennai, 8. Reagents/ Kits for Tamil Nadu 600032 Detection of Dengue 7) Department of Clinical Virology, Institute of Liver & Biliary Sciences, D-1, Vasant Kunj New Delhi-70 8) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 9) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 10) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 11) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 1) ICMR-National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 2) ICMR- National Institute of Cholera and Enteric Diseases,P- 33, C.I.T. Road, Scheme XM, In vitro Diagnostic Beleghata, Kolkata 700010 Reagents/ Kits for 9. 3) ICMR- Vector Control Research Centre, Medical Detection of Complex, VCRC Road, Indra Nagar, Priyadarshini Chikungunya Nagar, Puducherry, 605006 4) ICMR- National Institute of Malaria Research (NIMR), Sector 8, Dwarka, Delhi-110077 (India) 5) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Page 5 of 10Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 6) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 7) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 8) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 1) National Institute of Biologicals, Plot No. A-32, Sector-62, Institutional Area, Noida, Uttar Pradesh 201309 2) ICMR-National AIDS Research Institute. (ICMR). 73, 'G'-Block MIDC Bhosari, Pune - 411026, Maharashtra, India (Including HIV, HBV, HCV & Syphilis in single kit) 3) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India (Including HIV, HBV, HCV & Syphilis in single kit) 4) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 In vitro Diagnostic 5) ICMR-National Institute of Epidemiology, R 127, Reagents/ Kits for 3rd Avenue, Second Main Road, Tamil Nadu 10. Detection of Housing Board, Ayapakkam, Near Ambattur, Treponema pallidum Chennai, Tamil Nadu 600077 (Syphilis) 6) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 7) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 8) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 9) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 10) Department of Biological Control, King Institute of Preventive Medicine & research Guindy, Chennai-600032, Tamil Nadu 1) ICMR-National Institute for Research in Trible Health, Nagpur Road, Near NSCB Medical College Jabalpur, Madhya Pradesh, 482003. 2) ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, In vitro Diagnostic Beliaghata, Kolkata-700010 11. Reagents/ Kits for 3) Dept. of Microbiology, The Postgraduate Institute of Detection of Typhoid Medical Education and Research, Chandigarh, Sector 12, Chandigarh, 160012 4) Rajiv Gandhi Centre for biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 Page 6 of 105) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 7) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 1) ICMR- National Institute of Virology, 20/ A, Dr. Ambedkar Road, Post Box No. 11 Pune 411001, India 2) ICMR-Regional Medical Research Centre, N.E. Region, P.O.- Lahowal, Dibrugarh - 786 010 Assam, INDIA 2) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 3) Department of Clinical Virology, Institute of Liver & In vitro Diagnostic Biliary Sciences, D-1, Vasant Kunj, New Delhi-70 12. Reagents/ Kits for 4) Sawai Man Singh Medical College, Jawahar Lal Detection of Influenza Nehru Marg, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 5) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 6) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 7) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) Division Bacteriology, ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata , Kolkata-700010 2) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 3) Rajiv Gandhi Centre for Biotechnology In vitro Diagnostic Thiruvananthapuram, Kerala Melarannoor Road, Reagents/ Kits for 13. Behind Central Jail Poojapura, Thycaud, Detection of Thiruvananthapuram, Kerala 695014 Toxoplasma Gondii 4) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 5) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 6) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 1) ICMR- National Institute of Virology, 20/ A, Dr. In vitro Diagnostic Ambedkar Road, Post Box No. 11 Pune 411001, Reagents/ Kits for India 14. Detection of Rubella 2) ICMR- National Institute for Research in Virus & Reproductive Health, Jehangir Merwanji Street, Cytomegalovirus Parel, Mumbai, Maharashtra 400012 Page 7 of 103) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 4) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 5) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 2) ICMR-National Institute for Research in Tuberculosis, Mayor Sathiyamoorthy Road, In vitro Diagnostic Chetpet, Chennai – 600 031, India Reagents/ Kits for 3) Rajiv Gandhi Centre for Biotechnology 15. Detection of Thiruvananthapuram, Kerala Melarannoor Road, Pneumonia Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 4) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 5) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 2) ICMR-National Institute of Cholera and Enteric Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 3) Dept. of microbiology, All India Institute of Medical In vitro Diagnostic Sciences, Sijua, Patrapada, Bhubaneswar, Odisha Reagents/ Kits for 751019 Detection of 4) Rajiv Gandhi Centre for Biotechnology 16. Methicilline-Resistant Thiruvananthapuram, Kerala Melarannoor Road, Staphylococcus Behind Central Jail Poojapura, Thycaud, Aureus Thiruvananthapuram, Kerala 695014 5) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 7) National Institute of Mental Health and Neurosciences, Hosur Road, Near Bangalore Milk Dairy, Bengaluru, Karnataka - 560029 In vitro Diagnostic 1) ICMR- National Institute of Virology, 20/ A, Dr. Regents/Kits for Ambedkar Road, Post Box No. 11 Pune 411001, 17. detection of Entero India Virus (A/B) 2) ICMR-National Institute of Cholera and Enteric Page 8 of 10Diseases, P-33 C.I.T. Road, Scheme-XM, Beliaghata, Kolkata-700010 3) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 4) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 5) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 2) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 3) Division of Genetics, Dept. of Paediatrics’, All India Institute of Medical Sciences, New Delhi 4) Division of Genetics, Dept. of Paediatrics’, Maulana In vitro Diagnostic Azad Medical College, New Delhi Reagents/ Kits for 5) Any Central Government or State Government 18. Detection of markers Laboratory of any hospital or of any institute. for Congenital 6) Rajiv Gandhi Centre for Biotechnology disorders Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 7) All India Institute of Medical Sciences, Patna Phulwarisharif, Patna, Bihar- 801507, India 8) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 9) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 1) ICMR- National Institute for Research in Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 2) ICMR-Regional Medical Research Centre, NALCO Nagar, Chandrasekharpur, Bhubaneswar, Odisha 751023 3) ICMR- National Institute of Virology, 20/ A, Dr. In vitro Diagnostic Ambedkar Road, Post Box No. 11 Pune 411001, Reagents/ Kits for India 19. Detection of 4) Rajiv Gandhi Centre for Biotechnology Neisseria Thiruvananthapuram, Kerala Melarannoor Road, Gonorrhoeae Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 5) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 In vitro Diagnostic 1) ICMR- National Institute of Virology, 20/ A, Dr. 20. Reagents/ Kits for Ambedkar Road, Post Box No. 11 Pune 411001, Page 9 of 10Detection and typing India of Human Papilloma 2) ICMR- National Institute for Research in Virus infection Reproductive Health, Jehangir Merwanji Street, Parel, Mumbai, Maharashtra 400012 3) ICMR-National Institute of Epidemiology, R 127, 3rd Avenue, Second Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur, Chennai, Tamil Nadu 600077 4) Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram, Kerala Melarannoor Road, Behind Central Jail Poojapura, Thycaud, Thiruvananthapuram, Kerala 695014 5) All India Institute of Medical Sciences, Bathinda, Mandi, Dabwali Road, Bathinda Punjab-151001 6) All India Institute of Medical Sciences, Raebareli, Dalmau Rd, Munshiganj, Uttar Pradesh 229405 In vitro Diagnostic Any Central Government or State Government Reagents/ Kits for Laboratory of any hospital or of any institute. 21. Detection of autoimmune Disorders In vitro Diagnostic Any Central Government or State Government Reagents/ Kits for Laboratory of any hospital or of any institute. 22. human Genetic testing *** Page 10 of 10

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